The following data is part of a premarket notification filed by Biodynamics Corp. with the FDA for Chemstrip L.
| Device ID | K811189 |
| 510k Number | K811189 |
| Device Name: | CHEMSTRIP L |
| Classification | Test, Leukocyte Alkaline Phosphatase |
| Applicant | BIODYNAMICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GHD |
| CFR Regulation Number | 864.7660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-29 |
| Decision Date | 1981-07-27 |